BETAHISTINE HYDROCHLORIDE 16MG TABLETS
Active substance(s): BETAHISTINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BETAHISTINE DIHYDROCHLORIDE
8mg AND 16mg TABLETS
Read all of this leaflet carefully before you start to take your medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness
are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.
WHAT YOUR MEDICINE IS
The name of your medicine is Betahistine Dihydrochloride 8mg or 16mg Tablets. Betahistine dihydrochloride is
a type of medicine called a histamine analogue. It is
used as a treatment for Ménière’s syndrome, a condition
caused by the pressure of excess fluid in the inner ear.
Betahistine dihydrochloride is thought to work by
improving blood flow in the inner ear, which reduces the
build up of pressure. It is this pressure in the ear which is
thought to cause the vertigo (dizziness), tinnitus (ringing
in the ears) and hearing loss suffered by people with
Ménière’s disease
WHAT YOU NEED TO KNOW BEFORE
2. YOU
TAKE YOUR MEDICINE
Do not take your medicine if you:
• have ever had an allergic reaction to betahistine
dihydrochloride or any of the other ingredients listed in
section 6, Contents of the pack and other information
• have phaeochromocytoma (a tumour associated with
the adrenal gland which causes high blood pressure)
Warnings and precautions
Take special care and tell your doctor if you :
• have or have ever had a stomach or intestinal ulcer
• have asthma
• have a condition called porphyria
• are pregnant or planning to become pregnant
• are breast-feeding
If any of the above applies to you, talk to your doctor
before taking this medicine. Your doctor will tell you
whether it is safe for you to start taking this medicine.
Your doctor may also want to monitor your asthma while
you take this medication.
Taking other medicines
Please inform your doctor or pharmacist if you are
taking, or have recently taken any other medicine, even
those not prescribed by a doctor. In particular, tell your
doctor or pharmacist if you are taking any of the following medicines:
• Antihistamines, which are used to relieve allergic
conditions (e.g. terfenadine, diphenhydramine and
chlorpheniramine).
This medicine may take some time to have its full effect,
so do not worry if you do not feel better right away. Your
doctor may adjust the dose depending on your
response. Do not adjust the dose unless told to do so by
your doctor.
Use in Children and adolescents
This medicine should not be given to children under the
age of 18 years.
WHAT IS IN THIS LEAFLET
1. What your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. AND WHAT IT IS USED FOR
Adults
The recommended dose is 16mg three times daily
(48mg), preferably taken with meals.
How to stop taking your medicine
Keep taking your tablets until your doctor tells you to
stop.
These may in theory lower the effect of this medicine.
This medicine may also lower the effect of
antihistamines
• Monoamine-oxidase inhibitors (MAOIs) - used to treat
depression or Parkinson’s disease. These may inhibit
metabolism of Betahistine Dihydrochloride.
Taking this medicine with food and drink
You can drink alcohol while taking this medicine.
You can take this medicine with or without food.
Pregnancy and breast-feeding
Do not take Betahistine Dihydrochloride if you are
pregnant unless your doctor has decided that it is
absolutely necessary. Ask your doctor for advice.
Do not breast-feed while using Betahistine Dihydrochloride unless instructed by your doctor. It is not known if
Betahistine Dihydrochloride passes into breast milk.
Driving and using machinery
It is unlikely that these tablets will affect your ability to
drive or operate machinery. However remember the
diseases for which you are being treated with betahistine
(vertigo, tinnitus and hearing loss associated with
Meniere’s syndrome) can make you feel dizzy or be sick
and can affect your ability to drive or use machines.
Important information about one of the ingredients
in your medicine
These tablets contain lactose monohydrate. If you have
been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE YOUR MEDICINE
These tablets have been prescribed for you by a doctor.
Always take them exactly as he or she has told you.
Please read the label carefully. Check with your doctor
or pharmacist if you are not sure.
The tablets should be swallowed whole with a sufficient
quantity of liquid (e.g. one glass of water).
Take the tablet with or after a meal.
Even when you start feeling better, your doctor may want
you to carry on taking the tablets for some time to make
sure that the medicine has worked completely.
If you take more of your medicine than you should
If you take more tablets than you should, tell your doctor
immediately or go to the nearest hospital. Take the
medicine pack with you.
If you forget to take your medicine
Take your tablets as soon as you remember. If it is
almost time for your next dose, wait until that is due and
continue as normal. Do not take a double dose to make
up for the forgotten dose. Do not take two doses within
approximately two hours of each other.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betahistine Dihydrochloride Tablets
can cause side effects although not everybody gets
them.
STOP taking Betahistine Dihydrochloride Tablets
and see your doctor or nearest hospital casualty
department IMMEDIATELY if you experience:
• an allergic reaction. Symptoms of an allergic reaction
include; skin rashes, inflamed itchy skin, swelling of
the lips, face, throat or tongue, difficulty breathing or
swallowing.
Other common side effects (may affect up to 1 in 10)
are:
• feeling sick (nausea)
• headaches
• indigestion (dyspepsia)
Other side effects (frequency not known-cannot be
estimated from the available data)
• mild gastric complaints such as being sick (vomiting)
• abdominal pain and bloating
• stomach upsets
• itching and skin rashes
• Swelling of the skin (angioneurotic oedema)
• Hives
Taking this medicine with food can help reduce any
stomach problems.
If any side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
Also you can help to make sure that medicines remain
as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.
5. HOW TO STORE YOUR MEDICINE
KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use your medicine after the expiry date printed on
the package. The expiry date refers to the last day of
that month.
Do not store above 25°C. Store the tablets in the original
package.
This medicine should preferably be locked in a cupboard
or medicine cabinet.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
CONTENTS OF THE PACK
6. AND
OTHER INFORMATION
What this medicine contains and what it looks like
Betahistine Dihydrochloride 8mg Tablets: White, circular,
flat tablets marked with B8 on one side. Each tablet
contains 8mg betahistine dihydrochloride.
Betahistine Dihydrochloride 16mg Tablets: White,
circular, flat tablets marked with B16 on one side and a
breakline on the other side. Each tablet contains 16mg
betahistine dihydrochloride.
The tablets also contain povidone K90, microcrystalline
cellulose, lactose monohydrate, colloidal anhydrous
silica, crospovidone and stearic acid.
Pack sizes: 60, 84, 90, 100 and 120 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co.
Roscommon, Ireland.
Distributor
Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK
Manufacturers responsible for batch release
Kent Pharmaceuticals Limited, Crowbridge Road,
Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
PL 30464/0019 and PL 30464/0020
This leaflet was last revised in April 2014.
A0391/Lt3
A0305/Lt3
A0304/Lt3
BETAHISTINE DIHYDROCHLORIDE
8mg AND 16mg TABLETS
Read all of this leaflet carefully before you start to take your medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness
are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet.
WHAT YOUR MEDICINE IS
The name of your medicine is Betahistine Dihydrochloride 8mg or 16mg Tablets. Betahistine dihydrochloride is
a type of medicine called a histamine analogue. It is
used as a treatment for Ménière’s syndrome, a condition
caused by the pressure of excess fluid in the inner ear.
Betahistine dihydrochloride is thought to work by
improving blood flow in the inner ear, which reduces the
build up of pressure. It is this pressure in the ear which is
thought to cause the vertigo (dizziness), tinnitus (ringing
in the ears) and hearing loss suffered by people with
Ménière’s disease
WHAT YOU NEED TO KNOW BEFORE
2. YOU
TAKE YOUR MEDICINE
Do not take your medicine if you:
• have ever had an allergic reaction to betahistine
dihydrochloride or any of the other ingredients listed in
section 6, Contents of the pack and other information
• have phaeochromocytoma (a tumour associated with
the adrenal gland which causes high blood pressure)
Warnings and precautions
Take special care and tell your doctor if you :
• have or have ever had a stomach or intestinal ulcer
• have asthma
• have a condition called porphyria
• are pregnant or planning to become pregnant
• are breast-feeding
If any of the above applies to you, talk to your doctor
before taking this medicine. Your doctor will tell you
whether it is safe for you to start taking this medicine.
Your doctor may also want to monitor your asthma while
you take this medication.
Taking other medicines
Please inform your doctor or pharmacist if you are
taking, or have recently taken any other medicine, even
those not prescribed by a doctor. In particular, tell your
doctor or pharmacist if you are taking any of the following medicines:
• Antihistamines, which are used to relieve allergic
conditions (e.g. terfenadine, diphenhydramine and
chlorpheniramine).
This medicine may take some time to have its full effect,
so do not worry if you do not feel better right away. Your
doctor may adjust the dose depending on your
response. Do not adjust the dose unless told to do so by
your doctor.
Use in Children and adolescents
This medicine should not be given to children under the
age of 18 years.
WHAT IS IN THIS LEAFLET
1. What your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. AND WHAT IT IS USED FOR
Adults
The recommended dose is 16mg three times daily
(48mg), preferably taken with meals.
How to stop taking your medicine
Keep taking your tablets until your doctor tells you to
stop.
These may in theory lower the effect of this medicine.
This medicine may also lower the effect of
antihistamines
• Monoamine-oxidase inhibitors (MAOIs) - used to treat
depression or Parkinson’s disease. These may inhibit
metabolism of Betahistine Dihydrochloride.
Taking this medicine with food and drink
You can drink alcohol while taking this medicine.
You can take this medicine with or without food.
Pregnancy and breast-feeding
Do not take Betahistine Dihydrochloride if you are
pregnant unless your doctor has decided that it is
absolutely necessary. Ask your doctor for advice.
Do not breast-feed while using Betahistine Dihydrochloride unless instructed by your doctor. It is not known if
Betahistine Dihydrochloride passes into breast milk.
Driving and using machinery
It is unlikely that these tablets will affect your ability to
drive or operate machinery. However remember the
diseases for which you are being treated with betahistine
(vertigo, tinnitus and hearing loss associated with
Meniere’s syndrome) can make you feel dizzy or be sick
and can affect your ability to drive or use machines.
Important information about one of the ingredients
in your medicine
These tablets contain lactose monohydrate. If you have
been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE YOUR MEDICINE
These tablets have been prescribed for you by a doctor.
Always take them exactly as he or she has told you.
Please read the label carefully. Check with your doctor
or pharmacist if you are not sure.
The tablets should be swallowed whole with a sufficient
quantity of liquid (e.g. one glass of water).
Take the tablet with or after a meal.
Even when you start feeling better, your doctor may want
you to carry on taking the tablets for some time to make
sure that the medicine has worked completely.
If you take more of your medicine than you should
If you take more tablets than you should, tell your doctor
immediately or go to the nearest hospital. Take the
medicine pack with you.
If you forget to take your medicine
Take your tablets as soon as you remember. If it is
almost time for your next dose, wait until that is due and
continue as normal. Do not take a double dose to make
up for the forgotten dose. Do not take two doses within
approximately two hours of each other.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betahistine Dihydrochloride Tablets
can cause side effects although not everybody gets
them.
STOP taking Betahistine Dihydrochloride Tablets
and see your doctor or nearest hospital casualty
department IMMEDIATELY if you experience:
• an allergic reaction. Symptoms of an allergic reaction
include; skin rashes, inflamed itchy skin, swelling of
the lips, face, throat or tongue, difficulty breathing or
swallowing.
Other common side effects (may affect up to 1 in 10)
are:
• feeling sick (nausea)
• headaches
• indigestion (dyspepsia)
Other side effects (frequency not known-cannot be
estimated from the available data)
• mild gastric complaints such as being sick (vomiting)
• abdominal pain and bloating
• stomach upsets
• itching and skin rashes
• Swelling of the skin (angioneurotic oedema)
• Hives
Taking this medicine with food can help reduce any
stomach problems.
If any side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
Also you can help to make sure that medicines remain
as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.
5. HOW TO STORE YOUR MEDICINE
KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use your medicine after the expiry date printed on
the package. The expiry date refers to the last day of
that month.
Do not store above 25°C. Store the tablets in the original
package.
This medicine should preferably be locked in a cupboard
or medicine cabinet.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
CONTENTS OF THE PACK
6. AND
OTHER INFORMATION
What this medicine contains and what it looks like
Betahistine Dihydrochloride 8mg Tablets: White, circular,
flat tablets marked with B8 on one side. Each tablet
contains 8mg betahistine dihydrochloride.
Betahistine Dihydrochloride 16mg Tablets: White,
circular, flat tablets marked with B16 on one side and a
breakline on the other side. Each tablet contains 16mg
betahistine dihydrochloride.
The tablets also contain povidone K90, microcrystalline
cellulose, lactose monohydrate, colloidal anhydrous
silica, crospovidone and stearic acid.
Pack sizes: 60, 84, 90, 100 and 120 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co.
Roscommon, Ireland.
Distributor
Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK
Manufacturers responsible for batch release
Kent Pharmaceuticals Limited, Crowbridge Road,
Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham,
DE12 7DT, U.K.
PL 30464/0019 and PL 30464/0020
This leaflet was last revised in April 2014.
A0391/Lt3
A0305/Lt3
A0304/Lt3
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
